EMA QRD Templates
Support for Translations in Medicinal Product Submissions at Day 180 and Beyond: Ensuring Accuracy and Compliance with MPS Translations
Navigating the complex regulatory landscape for medicinal product submissions requires precision, particularly during the critical Day 180 review process. At MPS Translations, we specialize in providing high-quality translation services that meet the stringent requirements of regulatory authorities like the European Medicines Agency (EMA). This article explores the importance of accurate translations in the medicinal product submission process and how MPS Translations can support your needs, including updates after the CHMP opinion at Day 210.
The Importance of Accurate Translations in Medicinal Product Submissions
The centralized procedure for marketing authorizations in the European Union involves a meticulous linguistic review to ensure that all product information is clear, accurate, and compliant with regulatory standards. According to the European Medicines Agency (EMA), translations are a crucial component of the submission process, particularly at Day 180 when the linguistic review is conducted.
What Happens at Day 180?
Day 180 marks a pivotal point in the evaluation of medicinal products. By this stage, the EMA has completed its scientific assessment, and the focus shifts to the linguistic review of product information, including:
- Summary of Product Characteristics (SmPC)
- Package Leaflets (PL)
- Labelling texts
The linguistic review ensures that the translated texts are consistent, accurate, and meet the regulatory standards of all EU member states. This process is vital for preventing misunderstandings and ensuring that healthcare professionals and patients receive clear and precise information.
Day 210 Update and Final Version Delivery
In addition to the Day 180 review, MPS Translations provides crucial support at Day 210, when the Committee for Medicinal Products for Human Use (CHMP) issues its opinion. We offer:
- Rapid Updates: We can update your translations within 5 days following the CHMP opinion at Day 210.
- Final Version Delivery: We deliver the final, updated version by Day 215, ensuring that all changes are incorporated promptly and accurately.
Compliance and Quality Assurance
Our translation services ensure full compliance with:
- MedDRA Terminology: Adhering to the Medical Dictionary for Regulatory Activities (MedDRA) terminology for consistency and accuracy.
- EDQM Standard Terms: Using standard terms from the European Directorate for the Quality of Medicines & HealthCare (EDQM).
- QRD EMA Templates: Following the Quality Review of Documents (QRD) templates from the EMA.
- Submission-Ready Layout: Ensuring that all documents are formatted and ready for submission.
Linguistic Review Support
Further enhancing our service offering, MPS Translations can take over the linguistic review directly after submission, working with the various regulatory authorities to ensure compliance and accuracy.
Challenges in the Translation Process
The linguistic review process presents several challenges, including:
- Consistency: Ensuring that terminology is consistent across all documents.
- Accuracy: Translating technical and medical terms accurately.
- Compliance: Adhering to the regulatory requirements and guidelines set by the EMA and other authorities.
How MPS Translations Can Help
At MPS Translations, we understand the critical nature of the Day 180 review and the subsequent updates at Day 210. We offer specialized translation services to support your medicinal product submissions:
- Expert Translators
Our team consists of expert translators with extensive experience in the pharmaceutical and medical fields. They understand the specific terminology and regulatory requirements, ensuring that your documents are translated accurately and effectively.
- Quality Assurance
We employ a rigorous quality assurance process to ensure that all translations are consistent, accurate, and compliant with regulatory standards. This includes multiple rounds of review and validation by subject matter experts.
- Regulatory Compliance
We stay up-to-date with the latest regulatory guidelines and requirements from the EMA and other relevant authorities. This ensures that your translations are not only accurate but also fully compliant with current regulations.
- Timely Delivery
We understand the importance of meeting deadlines in the submission process. Our team is committed to delivering high-quality translations within the required timeframes, ensuring that your submissions proceed smoothly
Conclusion
The Day 180 review is a critical phase in the medicinal product submission process, requiring precise and compliant translations. Additionally, the ability to provide rapid updates following the CHMP opinion at Day 210 and delivering the final version by Day 215 is essential. At MPS Translations, we are dedicated to providing the highest quality translation services to support your needs. With our expertise, rigorous quality assurance, and commitment to regulatory compliance, you can trust us to help you navigate the complexities of the submission process.
For more information or to request a quote, visit MPS Translations today.
Keywords: medicinal product submissions, Day 180 review, MPS Translations, EMA, linguistic review, regulatory compliance, pharmaceutical translations, medical translations, quality assurance, CHMP opinion, Day 210 update.